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Substance Data Sheet: Chlorfenvinphos Stakeholder comments included inDRAFT-of 2009021

1Identity of Substance

*PS: priority substance; PHS: priority hazardous substance; PSR: priority substance under review; OSC: other substance of concern

2Proposed Quality Standards

2.1Overall Quality Standards

2.2Specific Quality Standards

#If justified by substance properties or data available, QS for the different protection objectives are given independently for freshwater environments, transitional waters or coastal and territorial waters

3Classification

4Physical and chemical properties

Amendments suggested by BASF in revision mode – acceptable ??

5Environmental Fate and Partitioning

Amendments suggested by BASF in revision mode – acceptable ??

Substance Data Sheet: Chlorfenvinphos Stakeholder comments included inDRAFT-of 2009021

6Effect Data (aquatic environment)

Table 6.1: Overview on Chlorfenvinphos aquatic toxicity data for most sensitive species from different sources (master reference)

*: fw = freshwater, sw = saltwater

Substance Data Sheet: Chlorfenvinphos Stakeholder comments included inDRAFT-of 2009021

Table 6.2:Mammal and bird oral toxicity data relevant for the assessment of non compartment specific effects relevant for the food chain (secondary poisoning)

France:

Invitation to consult the data bank AGRITOX on the internet site: agritox for further data on mammals, birds, and also ADI-values.

AGRITOX:

Bird acute oral tox: common starling (etourneau commun) - LD50 : 3.2 mg/kg bw/d
Véhicule : en solution dans le propyleneglycol (Source de l'information : Shell Chimie )

Adverse effects on reproduction (2 generation study with rats, oral uptake)

NOAEL = 0.05 mg/kg bw/d

(Source de l'information : FAO 1994 )

ECPA (BASF):

Chronic NOEC in rat (2-year) 0.3 ppm in diet (based on cholinesterase depression)

[Ref]Pickering, RG. 1980. Toxicity Studies on the Insecticide Chlorfenvinphos: A Two Year Feeding Study in Rats. Shell Research Limited, Sittingbourne Research Centre, Kent, UK, unpublished Report No. TLGR.80.021.

Northern Bobwhite LD50 (7 day) 99.8 mg/kg body wt.

[Ref]Troup, R. and Ahmed, M. 1997. Acute Toxicity Screening Study with Chlorfenvinphos in Northern Bobwhite (Colinus virginianus). Genesis Laboratories, Wellington, CO, USA, unpublished Report No. N97006.

Table 6.3:Summary on Endocrine Disrupting Potential

7Effect data (human health)

AGRITOX

ADI: 0.0005 mg/kg bw/d (FAO/WHO 1994)oral toxicity study with rats, 2 yrs

8Calculation of Quality Standards

8.1Quality Standards for Water

Freshwater

Aquatic toxicity data collated from different sources are summarized in table 6.1.

Freshwater crustaceans are the species that are most sensitive to chlorfenvinphos. Fish and algae appear to be less susceptible. The lowest chronic endpoint is the 21d NOEC of 0.1µg/l for reproduction of Daphnia magna. This NOEC is divided by the long term TER trigger (10) in order to derive the long term quality standard for freshwater.

QSfreshwater = 0.1 µg/l / TERlong-term (10) = 0.01 µg Chlorfenvinphos /l

Koc values between approximately 100 and 480 have been estimated for chlorfenvinphos (see section 5 of this data sheet). Hence, the log Kpsusp[1] is <1.7 and the trigger criterion to calculate the corresponding concentration to the QSfreshwater in SPM is not met (see section 8.4.1 of the final report [4]).

Denmark:

The Danish and the FhI proposal are compared: the database and the AF used are identical for the two standards.

UK:

Both the AA and MAC have been derived using the same value of 0,1 µg/l, despite being generated from different studies. The paper from which the data was used (Black et al., 1982) to derive the AA is flawed, as problems maintaining the test concentrations were encountered during the study (with actual concentrations ranging from 64,5 to 250% of the nominal dose).

Transitional, Coastal and Territorial Waters

Beside tests with freshwater species, toxicity tests with marine fish, crustacean and mollusc species have been submitted (see table 6.1). There are only few - mainly short term acute - tests with salt water species reported. The sensitivity of marine fish and molluscs for chlorfenvinphos is apparently comparable with the sensitivity of freshwater fish. The marine crustacean species Penaeus azeteus is less sensitve to chlorfenvinphos than freshwater daphnia, but as only one marine crustacean species has been tested no conclusions can be drawn on the basis of this result.

Chlorfenvinphos is a organophosphate insecticide and acaricide exerting its effect by inhibition of cholinesterase activity in the nervous tissue of target species. Hence, it is not deemed very probable that marine crustaceans in general are significantly less sensitive to this plant protection product than their relatives living in freshwater. Therefore, it is suggested to use the pooled data of freshwater and saltwater organisms for the derivation of the QSsaltwater. As toxicity data for an additional marine taxonomic group (molluscs) are available, it appears appropriate to set the same quality standard for saltwater as derived for freshwater:

QSsaltwater = QSfreshwater = 0.01 µg Chlorfenvinphos / l

France:

Complementary chronic ecotoxicological data for marine organisms should be obtained to confirm the hypothesis made with regard to the sensitivity of marine and freshwater organisms towards this substance. A “provisional" status should be given for transitional, coastal and territorial waters QS.

Quality Standard Accounting for Transient Concentration Peaks (MAC-QS)

Acute toxicity data are available for fish, crustaceans, algae, insects, amphibia, and molluscs.. An EC50 of 0.1 µg/l obtained with Daphnia magna is the lowest acute toxicity value available (see table 6.1).

It is suggested to derive the MAC-QS on the basis of this EC50 and the guidance given in the TGD on the effects assessment for intermittent releases (section 3.3.2 of part II of [3]).

Chlorfenvinphos is an insecticide and acaricide with a specific mode of action (inhibition of cholinesterase activity) and crustaceans belong to the most sensitive species. Thus, a reduced assessment factor of 10 is deemed appropriate for the derivation of the quality standard for transient concentration peaks..

MAC-QS = 0.1 µg/l / AF (10) = 0.01 µg Chlorfenvinphos /l

UK:

Both the AA and MAC have been derived using the same value of 0,1 µg/l, despite being generated from different studies. The paper from which the data was used (Black et al., 1982) to derive the AA is flawed, as problems maintaining the test concentrations were encountered during the study (with actual concentrations ranging from 64,5 to 250% of the nominal dose).

8.2Quality Standard for Sediment

The log Kpsusp of chlorfenvinphos is <1.7 (see footnote 1) and therefore the trigger criterion to calculate a sediment quality standard is not met.

8.3Secondary Poisoning of Top Predators

Chlorfenvinphos is classified as very toxic if swallowed and has a worst case BCF >100 (see section 5 of this data sheet). Thus the trigger criteria to derive a quality standard referring to the protection of top predators from secondary poisoning are met (see table 8.1 of the final report [4]).

However, results of oral toxicity studies with birds and/or mammals have not been submitted to the consultant. Therefore it is not possible to calculate a QS referring to secondary poisoning of top predators in this study.

According to the draft revised TGD NOECsfood from feeding studies with mammals (28 d, 90 d or chronic) or birds (chronic) are acceptable to assess secondary poisoning (see section 5.1.4.2 of the final report [4] and section 3.8.3.5 of the TGD [3]).

For Chlorfenvinphos a NOECfood from feeding studies with rats is available (0.3 mg/kg food, Shell Research unpubished report). According to the revised TGD[3] an assessment factor of 30 is appropriate to derive a PNEC from a chronic NOECfood for mammals. The PNECfood is equivalent to the "save" concentration in the prey of predators and thus is the quality standard for biota (QSsecpois.biota).

QSsecpois.biota = 0.3 mg/kg food / AF (30) = 10 µg Chlorfenvinphos / kg biota tissue (wet wt)

The BCFfish of 460 is used to calculate the concentration in water that corresponds to the QSsecpois.biota. No information is available on observations regarding biomagnification of Chlorfenvinphos.

According to the provisions given in the TGD [3] with regard to the assessment of secondary poisoning of top predators, biomagnification factors (BMF) should be taken into account for the calculation of the PECoral of top predators. However, the use of a default BMF as proposed in the TGD is not required as the relevant BCF is <2000 (see sections 5.1.4 and 5.1.6.3 of the final report [4] or sections 3.8.3 and 4.4.3 of the TGD [3] for details).

The QSsecpois.water is calculated as follows:

QSsecpois.water = QSsecpois.biota (10 [µg/kg]) / BCF (460 [kg/l]) = 0.022 µg Chlorfenvinphos /l

Thus, the protection of the pelagic community does require a lower QS than the protection of top predators from secondary poisoning (i.e. top predators are protected by the QS for freshwater or saltwater).

AGRITOX:

The NOAEL from feeding studies with rats (0.05 mg/kg bw/d) can be transformed to a NOECfood by multiplying it with a conversion factor of 20 (for rat, see table 22 of [3]).

NOECfood = NOAEL (0.05 mg) * CONV (20) = 1 mg/kg food

8.4QS referring to food uptake by Humans

Chlorfenvinphos is classified as very toxic if swallowed and has a worst case BCF >100 (see section 5 of this data sheet). Thus the trigger criteria to derive a quality standard referring to the protection of humans from adverse effects on health due to the ingestion of food from aquatic environments are met (see table 8.1 of the final report [4]).

However, results of oral toxicity studies with mammals that could be used to derive this standard have not been submitted to the consultant. Therefore it is not possible to calculate a QS referring to the protection of humans from adverse effects on health due to the ingestion of food from aquatic environments.

An acceptable daily intake for Chlorfenvinphos was estimated by FAO/WHO 1994 (ADI = 0.5 µg / kg bw d-1).

In the final report [4] it is suggested that the ADI may not be exhausted for more than 10% by consumption of food originating from aquatic sources. For a person weighing 70 kg this results in an acceptable daily intake of 35 µg Chlorfenvinphos per day.

The average fish consumption of an EU citizen is 115 g d-1 (TGD [3]). Thus, 115 g edible fish tissue (or fishery products) must not contain more than 35 µg Chlorfenvinphos.

35 µg Chlorfenvinphos

QShh.food = ------* 1000 g = 304 µg Chlorfenvinphos / kg fishery products

115g seafood consumption

In the TGD approach for the assessment of secondary poisoning (see sections 8.4.3, 5.1.4 and 5.1.6.2 of the final report [4]) it is foreseen to consider bioconcentration and biomagnification as relevant factors affecting body burdens and the PEC, respectively. If no information on BMF values is available, it is proposed in the TGD to use default BMFs for substances with a BCFfish >2000. However, as the BCFfish of Chlorfenvinphos is lower than the trigger value BMF needs not to be considered and the water concentration corresponding to the QShh.food can be calculated as follows:

QShh.food (304 [µg/kg])

QShh.food.water = ------= 0.66 µg Chlorfenvinphos / l

BCF (460 [l/kg])

Thus, the quality standard required to protect human health from adverse effects due to ingestion of food originating from aquatic environments is not as low as the respective standards required for the protection of freshwater and saltwater communities.

8.5QS for drinking water abstraction

The imperative A1 value referring to drinking water abstraction by simple treatment is 1 µg/l for the total amount of pesticides (Council Directive 75/440/EEC). The drinking water standard set in CD 98/83/EC is 0.1 µg/l for individual pesticides.

The QS derived for the protection of the pelagic community in freshwater (0.01 µg/l) is therefore also protective for drinking water abstraction. Hence, the derivation of a quality standard addressing drinking water abstraction is not necessary.

8.6Overall Quality Standard

The quality standard derived for the pelagic community (both in freshwater and saltwater) is protective for drinking water abstraction and sediments as well. It may be considered as provisional overall quality standard. However, chlorfenvinphos appears to be moderately bioaccumulating (worst case BCF >100) and is classified as very toxic if swallowed (R28). Therefore, it is required to assess whether the standard derived for the pelagic community is also sufficient to protect predators from secondary poisoning or humans from adverse effects due to ingestion of fishery products.

9.References

[1]UK response to request for information relating to quality standards for the Priority List. Submission of data on toxicity, persistence and bioaccumulation by DETR (e-mail of 23 May 2001 by Natasha Robinson)

[2]COM(2001)262 final: Communication from the Commission to the Council and the European Parliament on the implementation of the Community Strategy for Endocrine Disrupters – a range of substances suspected of interfering with the hormone system of humans and wildlife.

[3]Technical Guidance Document on Risk Assessment in Support of Commission Directive 93/67/EEC on Risk Assessment for New Notified Substances and Commission Regulation (EC) No 1488/94 on Risk Assessment for Existing Substances and Directive 98/8/EC of the European Parliament and the Council Concerning the placing of biocidal products on the market. Part II. Draft version of February 2002 sent out to the Member States for final comments.

[4]Final Report of the Study: Identification of quality standards for priority substances in the field of water policy. Towards the Derivation of Quality Standards for Priority Substances in the Context of the Water Framework Directive.

[5]Frimmel, FH et al., 2001: Ableitung von Qualitätszielen für Kandidatenstoffe der prioritären Liste für die EU-Wasserrahmenrichtlinie. Projektbericht zum Forschungsvorhaben. Substance data sheet for Chlorfenvinphos

[6]Excel - database provided by RIVM. Personal communication (e-mail Dr. Dick Sijm, 14 February 2002)

[7]Crommentuijn, T, et al.; 1997: Maximum Permissible Concentrations and Negligible Concentrations for Pesticides. National Institute of Public Heath and the Environment, Bilthoven. RIVM report no. 601501002

[8]Robson MM, 1992. Chlorfenvinphos (BIRLANE): Determination of Vapour Pressure According to EEC Requirements. Shell Research Limited, Sittingbourne Research Centre, Kent, UK, unpublished Report No. 6920-579/97.

[9]Robson, MM, 1993. Determination of the Physico-Chemical Properties of Chlorfenvinphos According to EEC Requirements. Shell Research Limited, Sittingbourne Research Centre, Kent, UK, unpublished Report No. 7242-579/130-A.

[10]Robson, MM. 1994. Determination of the Stability of Chlorfenvinphos: Hydrolysis and Photolysis. Shell Research Limited, Sittingbourne Research centre, Kent, UK, unpublished Report No. 579/130-C-1014.

[11]Jenkins, WR and Holman, J. 1998. AC 58053 (Chlorfenvinphos) Assessment of Ready Biodegradability: Modified Sturm Test. Huntingdon Life Sciences, Huntingdon, UK, unpublished Report No. CYD584/980130.

[12]Wahle, U. 1993. Chlorfenvinphos: Degradation in Water/Sediment Systems. Fraunhofer Institute, unpublished Report No. SHE-007/7-19.

[13]Pickering, RG. 1980. Toxicity Studies on the Insecticide Chlorfenvinphos: A Two Year Feeding Study in Rats. Shell Research Limited, Sittingbourne Research Centre, Kent, UK, unpublished Report No. TLGR.80.021.

[14]Troup, R. and Ahmed, M. 1997. Acute Toxicity Screening Study with Chlorfenvinphos in Northern Bobwhite (Colinus virginianus). Genesis Laboratories, Wellington, CO, USA, unpublished Report No. N97006.

[1]Kpsusp is the partition coefficient solid-water in suspended matter = Koc * foc (with foc 0.1; see TGD section 2.3.5.3 [3]). For the calculation of the Kpsusp (Koc * 0.1) it is suggested to use a Koc of 480 obtained from the experimental log Koc 2.68 used in [7].